Rasagiline 1mg Tablet (Brand Name: Azilect)

is a monoamine oxidase inhibitor type B (MAO-B) indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy (in early disease) and as adjunct therapy to levodopa (in later disease). It works to increase dopamine levels in the brain which aids to help symptoms of Parkinson’s disease. Rasagiline is taken as a once daily oral tablet, available as:

• Rasagiline 0.5mg Oral tablet - available without prior authorization
• Rasagiline 1mg Oral tablet - prior authorization required

Definitions

"Dopamine" is a type of neurotransmitter produced by the body which the nervous system uses to send messages between nerve cells.¹

"Parkinson’s disease" is a disorder of the central nervous system that affects movement often including tremors.

Medical Necessity Criteria for Initial Authorization

The Plan considers rasagiline 1mg tablet medically necessary when ALL of the following criteria are met:

1. The member is 18 years old or older; AND
2. The member has a documented diagnosis of Parkinson's disease; AND
3. The requested medication is being used for ONE (1) of the following:
   1. as monotherapy AND the member is unable to use or has tried and failed selegiline; or
   2. as adjunctive therapy to levodopa or other antiparkinsonian agents (e.g., dopamine agonists [such as pramipexole, ropinirole, bromocriptine, cabergoline], amantadine, anticholinergic agents [such as benztropine, trihexyphenidyl]) AND the member is unable to use or has tried and failed BOTH of the following:
      1. Selegiline; and
      2. Rasagiline 0.5mg Tablet;
   AND
4. Clinical chart documentation is provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met, rasagiline 1mg tablet will be approved for 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. recent chart documentation (within the last 12 months) shows the member has experienced therapeutic response to the requested medication as evidenced by ONE (1) of the following:
   1. clinical improvement in symptoms (e.g., improvement in mentation, activities of daily living, and/or motor function) since starting the requested medication; or
   2. disease stability (e.g., symptomatic control of motor symptoms as well as non-motor and behavioral symptoms) since starting the requested medication
   ²

Experimental or Investigational / Not Medically Necessary

Rasagiline 1mg tablet for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Azilect (rasagiline) [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals USA Inc; April 2021.
2. DeMaagd G, Philip A. Parkinson's Disease and Its Management: Part 3: Nondopaminergic and Nonpharmacological Treatment Options. P T. 2015;40(10):668-679.
3. Fernandez HH, Chen JJ. Monoamine oxidase-B inhibition in the treatment of Parkinson's disease. Pharmacotherapy. 2007; 27:174S-185S.
4. Fox, Susan H., et al. International Parkinson and movement disorder society evidence-based medicine review: update on treatments for the motor symptoms of Parkinson's disease. Movement Disorders 33.8 (2018): 1248-1266.
5. Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: The PRESTO Study. Arch Neurol. 2005; 62:241-8.
6. Rascol O, Brooks DJ, Melamed E et al for the LARGO study group. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): A randomised, double-blind, parallel- group trial. Lancet. 2005; 365:947-54.

Clinical Guideline Revision / History Information

Original Date: 11/05/2020
Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023